Recurrent Ventricular Tachycardia, Ventricular Arrhythmias, Ventricular Fibrillation, Ventricular Tachycardia
Conditions
Keywords
Electrical Storm, Dexmedetomidine, Ventricular Electrical Storm, Precedex, Recurrent Ventricular Arrhythmias, Recurrent Ventricular Tachycardia, Sedation
Brief summary
The objective of this study is to determine if there is a meaningful benefit to using the sedative medication dexmedetomidine in the acute treatment of patients with recurrent ventricular arrhythmias, known as electrical storm. This will be a multi-centre, double-blinded, placebo-controlled, randomized trial. Patients with electrical storm will be randomized to receive 48 to 72 hours of dexmedetomidine or placebo as part of their initial treatment in an intensive care unit.
Detailed description
Electrical storm (ES), defined as three or more sustained or treated ventricular arrhythmias in a 24-hour period, is a life-threatening condition that is associated with significant short- and long-term mortality. Autonomic dysfunction from increased sympathetic tone and the catecholamine surge from defibrillator shocks can precipitate recurrent ventricular arrhythmias and exacerbate ES. Although the mainstay of treatment are anti-arrhythmic drugs, sedative agents and procedures are commonly used to decrease sympathetic tone. These therapies have been studied in refractory ES but the benefit of early sedation remains unclear. Alpha-2 agonism with dexmedetomidine can provide conscious sedation without the need for mechanical ventilation. Dexmedetomidine has been found to reduce ventricular arrhythmia events in non-ES patients in the intensive care unit and in the peri-operative period. Its antiarrhythmic properties are thought to be due to catecholamine suppression, prolonging electrical refractory periods, and increasing vagal tone. Its rapid onset and favorable safety profile render alpha-2 agonism with dexmedetomidine a potentially valuable therapy for patients with ES. This study is a multi-centre, double-blinded, placebo-controlled, randomized trial that will evaluate the effectiveness of dexmedetomidine in the acute treatment of ES. Consecutive patients admitted to an intensive care unit will be randomized to receive dexmedetomidine or placebo at the time of presentation. The study drug will be titrated to a maintenance dose and continued for 48 hours before being weaned.
Interventions
DRUGDexmedetomidine
Dose range: 0.3 mcg/kg/hr to 1 mcg/kg/hr.
DRUGNormal saline
Programed as dexmedetomidine on infusion pump.
Sponsors
Ottawa Heart Institute Research Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Masking description
Double-blind
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
\- All patients admitted to an intensive care unit with electrical storm over the age of 18 years will be approached for enrollment.
Exclusion criteria
* Refractory shock lasting for more than 30 minutes unrelated to ventricular arrhythmias (VAs), defined as requiring two or more vasopressors * SCAI class D or E cardiogenic shock * Cardiac arrest(s) with a no-flow and low-flow total time of greater than 10 minutes prior to recruitment. * ST-segment elevation myocardial infarction (STEMI)-induced VA with signs of active ischemia. * Bradycardia with heart rate less than 40 beats per minute, bradycardia-induced ventricular tachyarrhythmia, second degree Mobitz type 2 or greater atrioventricular block in the absence of a pacemaker. * Pregnancy * Known dexmedetomidine allergy or intolerance * Inability to obtain consent from patient or substitute decision maker. * Patients who have received dexmedetomidine or clonidine during the 24 hours prior to randomization
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The primary outcome is a composite of the following: 1. All-cause in-hospital death AND/OR 2. Any in-hospital ventricular arrhythmia requiring treatment after study drug initiation. | Duration of index hospitalization - an average of 2 weeks | Defined as anytime after the participant starts receiving dexmedetomidine or normal saline placebo |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| All-cause in-hospital death | Duration of index hospitalization - an average of 2 weeks | Defined as anytime after the participant starts receiving dexmedetomidine or normal saline placebo |
| Ventricular arrhythmia requiring treatment after study drug initiation | Duration of index hospitalization - an average of 2 weeks | Defined as anytime after the participant starts receiving dexmedetomidine or normal saline placebo |
| Resuscitated cardiac arrest after study drug initiation | Duration of index hospitalization - an average of 2 weeks | Defined as anytime after the participant starts receiving dexmedetomidine or normal saline placebo |
| Renal failure requiring new initiation of renal replacement therapy after study drug initiation | Duration of index hospitalization - an average of 2 weeks | Defined as anytime after the participant starts receiving dexmedetomidine or normal saline placebo |
| Intubation following study drug initiation | Duration of index hospitalization - an average of 2 weeks | Defined as anytime after the participant starts receiving dexmedetomidine or normal saline placebo |
| Length of stay in the intensive care unit | Duration of index hospitalization - an average of 2 weeks | Defined as anytime after the participant starts receiving dexmedetomidine or normal saline placebo |
| Length of stay in hospital | Duration of index hospitalization - an average of 2 weeks | Defined as anytime after the participant starts receiving dexmedetomidine or normal saline placebo |
| Need for mechanical circulatory support device after study drug initiation | Duration of index hospitalization - an average of 2 weeks | Defined as anytime after the participant starts receiving dexmedetomidine or normal saline placebo |
| Ventricular Arrhythmia requiring treatment only during active study drug treatment | Duration of index hospitalization - an average of 2 weeks | Defined as anytime the participant is receiving dexmedetomidine or normal saline placebo |
| Pacing or treatment with isoproterenol for treatment of bradyarrhythmia after study drug initiation. | Duration of index hospitalization - an average of 2 weeks | Defined as anytime after the participant starts receiving dexmedetomidine or normal saline placebo |
Countries
Canada, United States
Contacts
CONTACTF. Daniel Ramirez, MD MSc
CONTACTBenjamin Hibbert, MD PhD
Outcome results
None listed